Our Science
BCAL Diagnostics Limited is an Australian biotechnology company dedicated to advancing early, non-invasive breast cancer diagnosis. For over a decade, we have been developing diagnostic technologies designed to complement mammograms and improve screening outcomes for women worldwide.
Our NATA-accredited commercial laboratory, equipped with advanced Liquid Chromatography Mass Spectrometry (LCMS) technology, is at the core of our scientific innovation and clinical service delivery – supporting both ongoing research and the commercial rollout of our diagnostic test.
Founded in 2010 and headquartered in Sydney, Australia, BCAL Diagnostics Limited is listed on the Australian Securities Exchange (ASX: BDX).
Lipids in Breast Cancer
Lipids are a diverse group of naturally occurring fatty molecules that play essential roles in the body’s structure, energy storage, and cell signaling. Unlike proteins or carbohydrates, lipids are hydrophobic, meaning they do not mix well with water. This unique property makes them critical components of cell membranes, where they help regulate communication between cells and maintain structural integrity.
Beyond their basic biological functions, lipids serve as key biomarkers for disease. Changes in lipid composition and metabolism are associated with various conditions, including cancer, cardiovascular diseases, and neurodegenerative disorders. In breast cancer, tumor cells often alter their lipid profiles to support rapid growth, evade the immune system, and resist treatment. BCAL has harnessed these changes in lipid profiles and developed assays to detect the presence/absence of breast cancer.
BCAL Diagnostics Breast Cancer Assay Technology
BCAL Diagnostics has developed a blood test for breast cancer screening and diagnosis. The assay measures a panel of lipids in blood plasma using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS). These lipid measurements are converted to a test score using a proprietary diagnostic algorithm
Cutting-Edge Laboratory Facilities
Sydney, Australia: Our NATA accredited commercial clinical laboratory, equipped with advanced Liquid Chromatography Mass Spectrometry (LCMS) technology, is at the core of our scientific innovation and clinical service delivery—supporting both ongoing research and the commercial rollout of BCAL’s diagnostic blood test.
Publications and Conferences
Peer-reviewed Publication (Discovery)
Discovery of Plasma Lipids as Potential Biomarkers Distinguishing Breast Cancer Patients from Healthy Controls describes the methodology and results from early discovery work that forms the basis of the technology that underpins BCAL Diagnostics Research.
The online publication can be found at: https://www.mdpi.com/1422-0067/25/21/11559
| Type | Title | Conference / Journal | Date | Sample Size | Study Focus |
|---|---|---|---|---|---|
| Conference presentation | Design of a Prospective Registry Study to Evaluate the Decision Impact and Clinical Utility of the lipidomic-based Blood Test BREASTEST Plus in Breast Cancer Screening | San Antonio Breast Cancer Symposium (SABCS) | Dec-25 | N/A | Design of the BREASTEST-plus Registry |
| Conference presentation | BREASTEST plus: Innovation for breast cancer screening in women with dense breasts | Royal Australian College of General Practitioners Conference | Nov-25 | 720 | Verification study results for BREASTEST plus |
| Conference presentation | BREASTEST plus – The Science Behind the Test | Breast Cancer Trials (BCT) | Jul-25 | 1,727 | Discovery, verification and validation study data for BREASTEST plus |
| Conference presentation | Verification of the BREASTEST assay in an Australian population – a novel liquid biopsy assay measuring lipid biomarkers for early-stage breast cancer screening | American Society of Clinical Oncology (ASCO) | Jun-25 | 720 | Verification study results for BREASTEST plus |
| Conference presentation | Discovery and development of a novel lipidomic-based liquid biopsy assay for breast cancer | Royal Australian College of Surgeons Annual Scientific Congress | May-25 | 1,318 | Discovery and verification study results for BREASTEST plus |
| Conference presentation | Method validation of the novel breast cancer lipid biomarker assay, BREASTEST plus™, using liquid chromatography tandem mass spectrometry | AUS-oMicS | May-25 | N/A | Analytical validation of BREASTEST plus |
| Journal Article – Original Research | Discovery of Plasma Lipids as Potential Biomarkers Distinguishing Breast Cancer Patients from Healthy Controls | International Journal of Molecular Sciences | Oct-24 | 598 | Lipid Biomarker Discovery |
| Conference presentation | The BREASTEST Study: Design of the clinical validation study for the novel liquid-biopsy test BREASTEST® for the detection of early-stage breast cancer | Leura International Breast Cancer Conference | Oct-24 | N/A | Design of the BREASTEST plus clinical validation study |
| Conference presentation | Development of an Artificial Intelligence-Based Breast Cancer Detection Model Using a Plasma Lipidomic Signature | Mass Spectrometry & Advances in the Clinical Lab (MSACL) | Mar-24 | 256 | Lipid Biomarker Discovery |
| Conference presentation | Development of an Artificial Intelligence-Based Breast Cancer Detection Model Using a Plasma Lipidomic Signature | San Antonio Breast Cancer Symposium (SABCS) | Dec-23 | 656 | Lipid Biomarker Discovery |
| Conference presentation | Advancements in the detection of localised breast cancer by lipidomic signature directly from plasma | Australasian Association for Clinical Biochemistry and Laboratory Medicine (AACB) | Oct-23 | 689 | Lipid Biomarker Discovery |
| Conference presentation | Advancements in Commercial Viability of a Blood Test for the Early Detection of Breast Cancer | American Association of Clinical Chemistry (AACC) | Jul-23 | 689 | Lipid Biomarker Discovery |
| Conference presentation | A patient-friendly breast cancer blood test | Breast Cancer Trials (BCT) | Jul-23 | 790 | Lipid Biomarker Discovery |
| Conference presentation | Lipidomic signature from plasma to detect localised breast cancer | American Society of Clinical Oncology (ASCO) | Jun-23 | 689 | Lipid Biomarker Discovery |
| Journal Article – Review | Biomarker Reproducibility Challenge: A Review of Non-Nucleotide Biomarker Discovery Protocols from Body Fluids in Breast Cancer Diagnosis | Cancers | May-23 | N/A | Review of liquid biopsy fluid types in breast cancer diagnostics field |
| Conference presentation | Detection of early-stage breast cancer in women by plasma lipidomic profiling | American Society of Clinical Oncology (ASCO) | Jun-22 | 689 | Lipid Biomarker Discovery |